Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Allergic rhinitis(AR) is one of the most common allergic disorders throughout the world.The conventional therapies are effective in alleviating symptoms but the efficacy are limited and not persistent. Furthermonre, the cost and side-effect are known defects. A classical Chinese herbal formula, has been used for AR for centries. Our study purpose is to evaluate the clinical efficacy and safety of this formula verus placebo in perennial allergic rhinitis (PAR).
Hypothesis: the classical herbal formula would improve the symptoms of PAR patients and change some immunological parameters in the peripheral blood when comparing with the placebo.
It is a randomized, double-blind, placebo-controlled trial.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Shi-Bi-Lin | Active Comparator | Consist of 6 herbal. 7.5 g Xanthium sibiricum Patrin ex Widder (Asteraceae, Fructus), 20 g Angelica dahurica (Fisch. ex Hoffm.) Benth. (Apiaceae, Radix), 7.5 g Saposhnikovia divaricata (Turcz.) Schischk. (Apiaceae, Radix),15 g Magnolia biondii Pamp., (Magnoliaceae, Flos), 5 g Gentiana scabra Bunge (Gentianaceae, Radix) and 5 g Verbena officinalis L. (Verbenaceae, Herba). |
|
| Placebo | Placebo Comparator | The placebo contained brown colored starch resembling the SBL powder |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Shi-Bi-Lin | Drug | 4 weeks of treatment, dose of 1 g (two capsules), twice daily |
|
| Measure | Description | Time Frame |
|---|---|---|
| Allergic Rhinitis Symptom Score Including Rhinorrhea, Nasal Obstruction, Sneezing, Itchy Nose and Itchy Eyes at Week 4 | The severity of PAR was evaluated by means of a daily symptom diary chart. Patients were instructed to grade retrospectively everyday before bedtime, their generalwell-being, nasalsymptoms (nasal blockage, rhinorrhea, nose itching, sneezing) and non-nasal symptoms(itching eyes, tearing eyes, redness of eyes, itching of ears or palate) on the diary chart. A 4-point severity scale from no symptoms (0), mild (1), moderated (2) to severe (3) was used. | 4 week |
| Measure | Description | Time Frame |
|---|---|---|
| Quality of Life (Difference Between Baseline and Week 4) | SF-36 QOL questionnaire administrated before and after treatment. It has eight domains: general health (GH), physical functioning (PF), social functioning (SF), role limitation caused by physical problems (RP), bodily pain (BP), role limitations caused by emotional problem (RE), mental health (MH), and vitality (VT). Each domain was started from 0 (worst health) to 100 (best health). |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Zhao Yu, PhD | Department of ENT, Prince of Wales Hospital, The Chinese University of Hong Kong | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of ENT, Prince of Wales Hospital | Hong Kong | Hong Kong | ||||
| Department of ENT, Yan Chai Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 7878553 | Background | Leung R, Ho P. Asthma, allergy, and atopy in three south-east Asian populations. Thorax. 1994 Dec;49(12):1205-10. doi: 10.1136/thx.49.12.1205. | |
| 9042070 | Background | Spector SL. Overview of comorbid associations of allergic rhinitis. J Allergy Clin Immunol. 1997 Feb;99(2):S773-80. doi: 10.1016/s0091-6749(97)70126-x. |
Not provided
Not provided
Confirmed perennial allergic rhinitis and have a positive skin test to house-dust mite, mold antigens and/or animal dander was required. Enter 1-week run-in-period, during which symptom diary was given to each subject for the evaluation of symptoms. Eligible case with total score higher than 4.
Recruitment started at Jan 2004. Patients were recruited as volunteers from the Prince of Wales hospital, the Yan Chai hospital and the Alice Ho Mui Ling Nethersole Hospital specialist clinics.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Shi-Bi-Lin | Consist of 6 herbal. 7.5 g Xanthium sibiricum Patrin ex Widder (Asteraceae, Fructus), 20 g Angelica dahurica (Fisch. ex Hoffm.) Benth. (Apiaceae, Radix), 7.5 g Saposhnikovia divaricata (Turcz.) Schischk. (Apiaceae, Radix),15 g Magnolia biondii Pamp., (Magnoliaceae, Flos), 5 g Gentiana scabra Bunge (Gentianaceae, Radix) and 5 g Verbena officinalis L. (Verbenaceae, Herba). |
| FG001 | Placebo | The placebo contained brown colored starch resembling the SBL powder |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Shi-Bi-Lin | Consist of 6 herbal. 7.5 g Xanthium sibiricum Patrin ex Widder (Asteraceae, Fructus), 20 g Angelica dahurica (Fisch. ex Hoffm.) Benth. (Apiaceae, Radix), 7.5 g Saposhnikovia divaricata (Turcz.) Schischk. (Apiaceae, Radix),15 g Magnolia biondii Pamp., (Magnoliaceae, Flos), 5 g Gentiana scabra Bunge (Gentianaceae, Radix) and 5 g Verbena officinalis L. (Verbenaceae, Herba). |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Allergic Rhinitis Symptom Score Including Rhinorrhea, Nasal Obstruction, Sneezing, Itchy Nose and Itchy Eyes at Week 4 | The severity of PAR was evaluated by means of a daily symptom diary chart. Patients were instructed to grade retrospectively everyday before bedtime, their generalwell-being, nasalsymptoms (nasal blockage, rhinorrhea, nose itching, sneezing) and non-nasal symptoms(itching eyes, tearing eyes, redness of eyes, itching of ears or palate) on the diary chart. A 4-point severity scale from no symptoms (0), mild (1), moderated (2) to severe (3) was used. | Posted | Dec 2008 | Mean | Standard Deviation | Unit Score | 4 week |
|
During the 4 week Follow up visit, clients may report any Adverse Event they experience.
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Shi-Bi-Lin | Consist of 6 herbal. 7.5 g Xanthium sibiricum Patrin ex Widder (Asteraceae, Fructus), 20 g Angelica dahurica (Fisch. ex Hoffm.) Benth. (Apiaceae, Radix), 7.5 g Saposhnikovia divaricata (Turcz.) Schischk. (Apiaceae, Radix),15 g Magnolia biondii Pamp., (Magnoliaceae, Flos), 5 g Gentiana scabra Bunge (Gentianaceae, Radix) and 5 g Verbena officinalis L. (Verbenaceae, Herba). |
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Zhao Yu | Department of Otorhinolaryngology, Head & Neck Surgery, West China Hospital, Sichuan University, China | yutzhao@gmail.com |
Not provided
| ID | Term |
|---|---|
| D012221 | Rhinitis, Allergic, Perennial |
| ID | Term |
|---|---|
| D065631 | Rhinitis, Allergic |
| D012220 | Rhinitis |
| D009668 | Nose Diseases |
| D012140 | Respiratory Tract Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C503350 | Shi-Bi-Lin herbal formula |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Placebo | Other | 4 weeks of colormatched placebo capsules, dose of 1 g (two capsules), twice daily |
|
| 4 week |
| Hong Kong |
| Hong Kong |
| 9643741 | Background | Worldwide variation in prevalence of symptoms of asthma, allergic rhinoconjunctivitis, and atopic eczema: ISAAC. The International Study of Asthma and Allergies in Childhood (ISAAC) Steering Committee. Lancet. 1998 Apr 25;351(9111):1225-32. |
| 11009751 | Background | Nash DB, Sullivan SD, Mackowiak J. Optimizing quality of care and cost effectiveness in treating allergic rhinitis in a managed care setting. Am J Manag Care. 2000 Jan;6(1 Suppl):S3-15; quiz S19-20. |
| 10077136 | Background | Bielory L, Lupoli K. Herbal interventions in asthma and allergy. J Asthma. 1999;36(1):1-65. doi: 10.3109/02770909909065150. |
| 11031328 | Background | Ziment I, Tashkin DP. Alternative medicine for allergy and asthma. J Allergy Clin Immunol. 2000 Oct;106(4):603-14. doi: 10.1067/mai.2000.109432. |
| 11562075 | Background | Schmolz M, Ottendorfer D, Marz RW, Sieder C. Enhanced resistance to Sendai virus infection in DBA/2J mice with a botanical drug combination (Sinupret). Int Immunopharmacol. 2001 Sep;1(9-10):1841-8. doi: 10.1016/s1567-5769(01)00108-4. |
| BG001 | Placebo | The placebo contained brown colored starch resembling the SBL powder |
| BG002 | Total | Total of all reporting groups |
| Year |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | Placebo | The placebo contained brown colored starch resembling the SBL powder |
|
|
| Secondary | Quality of Life (Difference Between Baseline and Week 4) | SF-36 QOL questionnaire administrated before and after treatment. It has eight domains: general health (GH), physical functioning (PF), social functioning (SF), role limitation caused by physical problems (RP), bodily pain (BP), role limitations caused by emotional problem (RE), mental health (MH), and vitality (VT). Each domain was started from 0 (worst health) to 100 (best health). | ITT | Posted | Dec 2008 | Mean | Standard Deviation | Unit Score | 4 week |
|
|
|
| 0 |
| 63 |
| 0 |
| 63 |
| EG001 | Placebo | The placebo contained brown colored starch resembling the SBL powder | 0 | 63 | 0 | 63 |
Not provided
Not provided
| D012130 |
| Respiratory Hypersensitivity |
| D010038 | Otorhinolaryngologic Diseases |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
| Bodily pain |
|
| General Health |
|
| Vitality |
|
| Socail functioning |
|
| Role limitation by emotional problem |
|
| Mental health |
|